Browse Device Recalls
5,321 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,321 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 5,321 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 16, 2025 | Automated Impella Controller (AIC) labeled as the following with correspondin... | Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer fail... | Class I | Abiomed, Inc. |
| Sep 9, 2025 | Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080 | The outer carton box label is for the JuggerKnot 1.0mm Mini products. However, the products withi... | Class II | Biomet, Inc. |
| Sep 5, 2025 | Philips L12-5 Ultrasound Transducer | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Sep 5, 2025 | Philips C9-4 Ultrasound Transducer | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Sep 5, 2025 | Philips X7-2 Ultrasound Transducer | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Sep 5, 2025 | Philips 3D6-2 Ultrasound Transducer | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Sep 5, 2025 | Philips OMNI III TEE Ultrasound Transducer | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Sep 5, 2025 | Philips Mini Multi TEE Ultrasound Transducer | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Sep 5, 2025 | Philips L17-5 Ultrasound Transducer | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Sep 5, 2025 | Philips OMNI II TEE Ultrasound Transducer | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Sep 5, 2025 | Philips X3-1 Ultrasound Transducer | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Sep 5, 2025 | Philips S4-1 Ultrasound Transducer | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Sep 5, 2025 | Philips S5-2 Ultrasound Transducer | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Sep 2, 2025 | Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) ... | Due to incorrect product label (Incorrect product name identified on outer packaging). | Class II | Berkeley Advanced Biomaterials, LLC |
| Aug 28, 2025 | Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12m... | The product in incorrectly labeled. The label indicates that the skive hole should be above the b... | Class II | Boston Scientific Corporation |
| Aug 28, 2025 | 1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V4... | a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may c... | Class II | Howmedica Osteonics Corp. |
| Aug 26, 2025 | Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P. | Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the curre... | Class II | OSSTEM Implant Co., Ltd. |
| Aug 26, 2025 | Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS. | Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the curre... | Class II | OSSTEM Implant Co., Ltd. |
| Aug 26, 2025 | Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS. | Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the curre... | Class II | OSSTEM Implant Co., Ltd. |
| Aug 25, 2025 | Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636... | Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet a... | Class II | LeMaitre Vascular, Inc. |
| Aug 21, 2025 | Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 10 single packs , Rx... | Labeling includes shelf life that has not been validated. | Class II | Folsom Metal Products, Inc. |
| Aug 21, 2025 | Frontier Devices, REF: 301.914S2, 14 mm Distraction Pin, 10 double packs , Rx... | Labeling includes shelf life that has not been validated. | Class II | Folsom Metal Products, Inc. |
| Aug 21, 2025 | Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double packs , R... | Labeling includes shelf life that has not been validated. | Class II | Folsom Metal Products, Inc. |
| Aug 21, 2025 | Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx... | Labeling includes shelf life that has not been validated. | Class II | Folsom Metal Products, Inc. |
| Aug 21, 2025 | Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx ... | Labeling includes shelf life that has not been validated. | Class II | Folsom Metal Products, Inc. |
| Aug 21, 2025 | Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx... | Labeling includes shelf life that has not been validated. | Class II | Folsom Metal Products, Inc. |
| Aug 18, 2025 | AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R. | Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAG... | Class II | Aesculap AG |
| Aug 18, 2025 | AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R. | Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAG... | Class II | Aesculap AG |
| Aug 15, 2025 | Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG ... | Reverse Shoulder humeral liners have an articular surface position outside of the dimensional spe... | Class II | Exactech, Inc. |
| Aug 15, 2025 | Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 3... | Reverse Shoulder humeral liners have an articular surface position outside of the dimensional spe... | Class II | Exactech, Inc. |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. Brilliance iCT SP, Model N... | The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... | Class II | Philips North America Llc |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite ... | The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... | Class II | Philips North America Llc |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. Ingenuity CT 728326, Model... | The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... | Class II | Philips North America Llc |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, ... | The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... | Class II | Philips North America Llc |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model... | The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... | Class II | Philips North America Llc |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728... | The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... | Class II | Philips North America Llc |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil... | The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... | Class II | Philips North America Llc |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. Big Bore RT, Model Number:... | The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... | Class II | Philips North America Llc |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Nu... | The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... | Class II | Philips North America Llc |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. Brilliance iCT, Model Numb... | The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... | Class II | Philips North America Llc |
| Aug 11, 2025 | Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use ... | Their is the potential for weak staining which may result in false negative CD20 identification. | Class II | Agilent Technologies Denmark ApS |
| Aug 11, 2025 | Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use ... | Their is the potential for weak staining which may result in false negative CD20 identification. | Class II | Agilent Technologies Denmark ApS |
| Aug 11, 2025 | Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use ... | Their is the potential for weak staining which may result in false negative CD20 identification. | Class II | Agilent Technologies Denmark ApS |
| Aug 8, 2025 | Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322 | Blood collection tubes were manufactured with the label applied too high on the tube, which shif... | Class II | Greiner Bio-One North America, Inc. |
| Aug 8, 2025 | Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ03827... | Convenience kits labeled as sterile have not gone through the sterilization process. | Class I | Medline Industries, LP |
| Aug 8, 2025 | Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B | Convenience kits labeled as sterile have not gone through the sterilization process. | Class I | Medline Industries, LP |
| Aug 1, 2025 | Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labele... | Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Aug 1, 2025 | Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.... | Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Aug 1, 2025 | Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R... | Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jul 30, 2025 | Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introdu... | Units may have been packaged with an incorrect pouch label, which lists the reference number and ... | Class II | Contract Medical International GmbH |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.